The World Trade Organization (WTO) is an international organization which deals with trade between nations. Its origins lie with the establishment of the General Agreement on Tariffs and Trade (GATT) in 1948, which aimed to reduce tariff barriers to trade in goods. As a result of GATT, an informal international organization developed but it wasn't until the final GATT round in 1994 (Uruguay Round) that a formal international organization was established (the WTO) to oversee the global trading system.
The WTO aims to lower trade barriers among member countries to ensure that trade is free and predictable. Its principles are based on the idea that reducing trade barriers promotes economic growth and prosperity and that trade between countries should be free from discrimination.
At the heart of the WTO are its trade agreements which have been negotiated and ratified by the majority of the world's trading nations (146 member countries as at 4th April 2003). The three key agreements cover trade in goods (the General Agreement on Tariffs and Trade), trade in services (the General Agreement on Trade in Services) and trade in ideas (the Agreement on Trade-Related Aspects of Intellectual Property). As a result of TRIPS, intellectual property has been linked inextricably with trade policy, making it a controversial and political agreement.
The WTO is overseen by a Ministerial Conference and a General Council. The Ministerial Conference meets at least once every two years and provides the mandate for negotiations on the international Agreements and other issues. The outcomes of the Conference are released as declarations, with the most recent declaration (the Doha Declaration) reporting on the meeting of the Ministerial Conference in 2001. The latest WTO Ministerial Conference in Cancun, Mexico in September 2003 broke down over basic disagreement on agriculture subsidies.
Trade-Related Aspects of Intellectual Property Rights (TRIPS) is arguably the most important and comprehensive international agreement on intellectual property rights. Member countries of the WTO are automatically bound by the agreement. The Agreement covers most forms of intellectual property including patents, copyright, trademarks, geographical indications, industrial designs, trade secrets and protection of new plant varieties.
The TRIPS agreement outlines several important trade related aspects of intellectual property. More specifically, it requires signatory countries to adhere to its criteria for intellectual property protection along with requiring adherence to the Paris Convention, Berne Convention and other WTO Conventions. The criteria are minimum standards of protection for IP as well as enforcement provisions and methods of IP dispute settlements.
When the TRIPS Agreement took effect on January 1, 1995, all developed countries were given twelve months from the date of signing the agreement to implement its provisions. Developing countries and transition economies (under certain conditions) were given five years, until 2000. Least developed countries (LDCs) were given 11 years, until 2006, to comply. For pharmaceutical patents in these LDCs, the term for compliance has been extended to 2016. There are currently 30 LDCs within the WTO organization bound by TRIPS and another 10 LDCs are waiting accession.
Some of the most important (and controversial) provisions in the TRIPS agreement concern patent protection. TRIPS signatories are obliged to make patents available for all inventions, whether products or processes, in all fields of technology without discrimination (Article 27.1). Interestingly, TRIPS does not define the term “invention”. The agreement states three exceptions that countries may rely on to exclude otherwise patentable subject matter. These include:
1) inventions which are contrary to ordre public or morality, i.e. inventions which are dangerous to human, animal or plant life or health or seriously prejudicial to the environment. (Article 27.2)
2) diagnostic, therapeutic and surgical methods for the treatment of humans or animals (Article 27.3(a)).
3) plants and animals other than microorganisms and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. Any country excluding plant varieties from patent protection must provide an effective sui generis system of protection (Article 27.3 (b)).
The interpretation of this last clause has been extremely contentious. The term sui generis (Latin for 'of its own gender/genus') is not defined in the agreement, however it is generally believed that it enables member countries to fashion their own protection scheme for plants. Possible protection mechanisms include the Plant Breeder's Rights system offered by UPOV Convention, plant patents or a licensing regime. More than one form of plant protection can be implemented in a given member country.
One of the controversies of Article 27.3 focuses on the meaning of 'sui generis' and exactly what is considered an 'effective' form of plant variety protection. In part because of the difficulties with this provision, Article 27.3 was to be reviewed in 1999, four years after the entry into force of the agreement. The review has never been completed, and this Article remains a hot issue. To date, some 30 countries are calling for further discussion on Article 27.3, and some have proposed:
1) rewriting the Article to exclude patents for any organisms or genetic material (although ostensibly countries could achieve this by defining these subject matters as “discoveries” and not “inventions”);
2) defining in detail what an effective plant variety protection system is;
3) extending protection to traditional or indigenous knowledge; and
4) making explicit linkages with obligations for the conservation and use of biodiversity, including mandatory disclosure of the source of genetic materials used in a patented invention, and creating obligations to record arrangements for access to genetic resources as evidence of prior informed consent.
It remains to be seen if any of these proposals will be adopted.
The rights obtainable by patentees are clearly outlined in Article 28. The Article also provides that rights are conferred for products which are directly obtained by a patented process or method.
EXAMPLE: If a patent is issued for a novel method of manufacturing snow skis, the skis produced will also be protected by the patent.
The TRIPS agreement provides that inventions must be disclosed by publication (Article 29) and sets out a minimum term of 20 years for patent protection. The 20 year term is calculated from the filing date (Article 33). Although a patent term begins at filing, enforcement rights only ensue from the date of patent grant.
TRIPS also provides rules regarding domestic procedures and remedies for the enforcement of intellectual property rights. The rules are general principles applicable to all enforcement procedures, i.e. they contain provisions on civil and administrative procedures and appropriate remedies so that right holders, be they patentees, copyright owners or other intellectual property owners, can effectively enforce their rights.
One of the effects of the TRIPS agreement has been to tie trade and intellectual property together. Traditionally, developing countries have opposed the range of nontariff barriers, such as the protection of inventions, which they see as preventing them from trading competitively throughout the rest of the world. Controversy has arisen over perceptions of inconsistency between the TRIPS Agreement and other international agreements, such as the Convention on Biological Diversity. There have also been suggestions, for example, that patenting restricts the availability of the latest chemicals, pharmaceuticals and fertilizers, thereby necessitating the use of older, less-safe and more toxic products. There have been reports that intellectual property rights on plant varieties erode biological diversity, especially in agriculture. Some countries are also demanding that the existing intellectual property system should accommodate concepts traditionally outside of the scope of intellectual property, for example indigenous and traditional knowledge.
The examples above highlight some of the issues surrounding the TRIPS agreement which are the subject of much international debate. For further discussion of the political implications surrounding these issues, see Genetically Engineered Food Alert Campaign’s website.
Some nine years after TRIPS was first implemented, its provisions are still in a state of review and alteration. For individual country positions on trips see: Grain’s TRIPS Review pages. Grain is an international non-governmental organisation which promotes the sustainable management and use of agricultural biodiversity based on people’s control over genetic resources and local knowledge.
Article 27 Patentable Subject Matter
3. Members may also exclude from patentability:
(b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.
Article 28 Rights Conferred
1. A patent shall confer on its owner the following exclusive rights:
(a) where the subject matter of a patent is a product, to prevent third parties
not having the owner's consent from the acts of: making, using, offering for
sale, selling, or importing for these purposes that product;
(b) where the subject matter of a patent is a process, to prevent third parties not having the owner's consent from the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process.
2. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.
The WTO Ministerial Conference is a meeting of the organization's highest-level decision making body. The fourth WTO Ministerial Conference was carried out in Doha, Qatar, in November 2001 and the outcomes of the meeting are referred to as the Doha Declaration.
During this meeting, the problems of developing countries in implementing the WTO agreements, notably the TRIPS agreement, were discussed, along with the interpretation of TRIPS and its relationship with other international agreements such as the Convention on Biological Diversity.
One of the most important outcomes of the meeting related to public health. Since the implementation of the TRIPS Agreement, one of the main issues of concern which has arisen is how to ensure that patent protection for pharmaceutical products does not prevent people in poor countries from having access to medicines.
To address this issue, the Ministers at the Doha meeting put forward a public health declaration which stressed that the TRIPS agreement must be interpreted in a way that supports public health via the easy accessibility to existing medicines and the creation of new medicines. It emphasized that the TRIPS Agreement does not prevent member governments from acting to protect public health and affirmed their right to use compulsory licensing (where a third party is allowed to reproduce the patented process or product under license) and parallel importing.
The separate declaration on health set forward two specific tasks for the TRIPS council. They were:
1) to find a solution to the problems countries may face in using compulsory licensing if a country has little or no pharmaceutical manufacturing capacity; and
2) to extend the exemptions on pharmaceutical patent protection for LDCs until 2016.
While the issue of public health was a major concern at this Conference, the Doha Declaration also instructed the TRIPS Council to continue with the review of Article 27.3 (b) of the TRIPS agreement and to examine the limitations and potential problems which surround the issue of granting IP protection of traditional knowledge. The progress on these revisions and examinations was to be reported at the fifth Ministerial Conference in Mexico in September 2003, however this meeting broke down over disagreements on agriculture subsidies.
The United Nations (UN) came into existence in 1945, when 50 countries met to draw up the United Nations Charter.The Charter is a comprehensive document detailing the rights and obligations of member States and establishing the organization's departments and procedures.
As outlined in the Charter, the objectives of the United Nations are:
1) to obtain international peace and security;
2) to develop friendly relations among nations;
3) to cooperate in solving international economic, social, cultural and humanitarian problems;
4) to promote respect for human rights and fundamental freedoms; and
5) to be a center for harmonizing the actions of nations in attaining these ends
The UN is more than a single body. It has 6 principal departments (including the General Assembly and the Security Council) and the United Nations family encompasses 15 agencies and numerous programs. To date the UN has 191 member countries.
For a complete listing of UN agencies and programs see: http://www.un.org/aboutun/chart.html
The World Intellectual Property Organization (WIPO) is an international organization dedicated to facilitating worldwide protection of the rights of creators and owners of intellectual property.
WIPO's origin dates back to 1883 in Geneva, Switzerland when the Paris Convention entered into force and an International Bureau was set up to carry out administrative tasks. This International Bureau evolved over time to become known in 1970 as WIPO. In 1974, WIPO became a specialized agency of the United Nations and in 1996, WIPO expanded its role into globalized trade by entering into a cooperation agreement with the World Trade Organization.
WIPO currently has 179 states that are members of the organization and administers 23 treaties (two of which are in conjunction with other international organizations). The 23 treaties administered by WIPO are divided into three classes:
1) Intellectual Property Treaties that define the internationally agreed basic standards of intellectual property protection; e.g. Paris Convention
2) Global Protection System Treaties that aim to ensure that one international registration or filing will have effect in any of the relevant signatory States; e.g. PCT and Budapest Treaty.
3) Classification Treaties that create systems that organize information concerning inventions into indexed structures to enable easy retrieval; e.g. International Patent Classification (IPC).
Through these treaties, WIPO seeks to harmonize national intellectual property legislation and procedures; provide services for international applications for industrial property rights; exchange intellectual property information; provide legal and technical assistance to developing countries; facilitate the resolution of private intellectual property disputes; and marshal information technology as a tool for storing, accessing and using valuable intellectual property information.
While the cornerstones of WIPO's treaty system remain the Paris Convention (relating to patents) and the Berne Convention (relating to copyright), subsequent treaties have not only widened and deepened the protection they offer, but have encompassed technological change and new areas of interest and concern. A selected number of patent treaties administered by WIPO are briefly presented below.
The Paris Convention is one of the Intellectual Property Treaties administered by WIPO. It was launched in 1883 in order to provide some international harmonizing and streamlining of intellectual property laws. There are 169 member countries (as of 3 January 2005).
Under the Convention, a member country is obliged to give nationals of other member countries the same protection and advantages as it grants to its own nationals. This anti-discrimination policy of the Convention is also a fundamental tenet of many other intellectual property agreements and treaties.
EXAMPLE: A French national applying for a patent in Japan will have the same patent rights and level of protection in Japan as a Japanese national.
The other fundamental tenet of the Paris Convention is a 'framework of priority'. Under the Paris Convention, an invention can be protected from the same point in time in a variety of countries. It is also a means of access into national patent systems for foreign applicants. An inventor is able to claim the filing date of his first patent application in a Convention country as an effective filing date for further subsequent applications (for the same invention) in any other member country. However, the later applications must be filed within 12 months of the earliest application in order to claim the priority date.
EXAMPLE: A United Kingdom patent application is lodged on 1 January, 2002. On 1 January 2003, the same patent application is filed in Mexico. Mexico is a Convention member and as a result, the Mexican application is treated as though it was filed on 1 January 2002.
If, without the treaty, the patent in the example was treated as though it was filed on 1 January 2003 in Mexico, the invention would likely already have been disclosed and thus unpatentable in Mexico.
The right of priority means that in the foreign Convention country, the patent application will be filed from the earliest date of filing in the home country for purposes of cited or prior art. This is beneficial to an inventor, as it allows the inventor to avoid detrimental effects of his or other's public disclosure that occurred after the earliest application and before filing in foreign countries.
EXAMPLE: A patent application for a video telephone is lodged in Djibouti. Eight months after lodging the application, the inventor displays his video telephone at an international conference. As a result of the conference worldwide publicity is generated for both the invention and the inventor, and the specifications of the video telephone become widely known. A lot of interest is generated in Australia and it becomes obvious to the inventor that it would be worthwhile to seek patent protection in Australia.
In the example above, the inventor has four months in which to seek patent protection in Australia. Even though he has publicly disclosed his invention throughout the world, he is still able to seek protection in Australia, provided that he files an application in Australia within twelve months of lodging his initial application in Djibouti.
Considering that obtaining patent protection can be an expensive process, the twelve month period also provides the inventor with a reasonable period of time to determine whether his invention is worth protecting in other countries.
The Patent Cooperation Treaty (PCT) is a Global Protection Treaty administered by WIPO. The Patent Cooperation Treaty aims to provide a simplified and less costly method of preserving the rights to file a patent application in member countries. It seeks to achieve this by providing what is known as a PCT application. To date, the Patent Cooperation Treaty has 123 member countries (Contracting states to the PCT).
A PCT application is NOT a primary patent application. Before a PCT application can be of use, a priority patent application for an invention must be filed in the inventor’s home country. After this priority date is obtained by the initial filing of the application, a PCT application may be used to preserve the right to file the same invention in all Patent Cooperation Treaty member countries. Given that PCT applications claim a priority date from the initial patent application, the PCT application acts as a placeholder, reserving the patent rights in member states designated on the application.
An inventor can designate as many member states as he desires in which to preserve his filing rights or, after 1/1/2004, all member countries are automatically chosen.
In order to obtain protection in each individual country the inventor chooses, it is necessary for the PCT to be converted (filed) in the national patent offices of the selected countries where the invention will be subject to an examination in order to meet the national requirements for novelty, obviousness etc. The administrative tasks, including translation if necessary and the fees associated with lodging patent applications in that country, must be complied with.
The PCT application can therefore act as a way of delaying the costs of filing in multiple national patent offices, until the inventor has decided whether it is worthwhile seeking protection in many countries.
EXAMPLE: An Indian national files a patent application on the 1/1/2003 at the Indian Patent Office. On the 1/1/2004 he then files a PCT application with WIPO designating Brazil, Egypt and China as contracting states. After deciding that there are commercial opportunities for his invention in Brazil, the applicant decides to file in Brazil six months after filing a PCT application (1/7/2004). The filing date for the Brazilian application will claim priority from the date that it was first filed in India, i.e. 1/1/2003. The 20 year term of patent protection (if granted in Brazil) will extend from the date of the PCT application (from 1/1/2004 to 1/1/2024). The inventor still has up to 12 months remaining in order to decide whether or not to file in Egypt and China.
Priority that stems from a PCT application can only be given in those countries which are designated on the application. In the example above, the inventor would not be able to claim the priority date of 1/1/2003 in Japan, as Japan was not specified as a designated country on the PCT application. However, under the changes to the PCT process which came into force in January, 2004, there is no longer a need for countries to be designated on the application as all member countries will automatically be chosen.
A PCT application is usually filed at any point in time up to 12 months from the initial or priority filing in the home country. At a period of 18 months after the initial application, the PCT application is published. It used to be that at 20 months after the initial filing date, the applicant must have entered the national phase of the application process in the designated states or lose his right to file claiming the earlier priority date. However, this period could be extended by a further 10 months if the applicant requested an examination or preliminary report. The examination gives an inventor a preliminary and non-binding opinion on the patentability of the claimed invention. He is then able to determine whether or not he should proceed with the conversion of the PCT application into numerous, individual national patents.
We are currently in a transitional period where changes to the PCT process are underway. It is now becoming possible in some countries for inventors to claim priority for 30 months after the initial filing, without having to request an examination at 20 months. This has not yet been implemented in all PCT member countries, as it requires each member country to change their national patent laws to reflect this extension of time. There is now one set international filing fee that applies to all applications, regardless of the number of countries that have been designated by the applicant.
Under the PCT process, an applicant can delay the expenses of filing for up to 30 months, while evaluating the desirability of filing in a particular country or raising the funds necessary to do so. The applicant also has the peace of mind of knowing that the application cannot be rejected on ‘prior art’ that has emerged in the time between the applicant making a PCT application and filing a national application.
Microorganisms that are naturally occurring cannot be the subject of patents. However, a naturally occurring microorganism that is manipulated or altered such as through gene insertion, mutation etc can be the subject of a patent.
Patent law requires that the details of an invention must be fully disclosed in order for others skilled in the relevant field to be able to replicate it. Disclosure is normally achieved by means of a written description and supplemented where necessary by drawings. In the case of inventions involving the use of microorganisms, these patentability requirements may be difficult to fulfill.
EXAMPLE: It would be almost impossible to describe an organism isolated from soil and improved by selection, e.g. mutation, so that another person could be guaranteed to isolate and improve exactly the same strain from the soil in exactly the same way.
To overcome these problems, intellectual property offices in many countries recommended that the written description of an invention involving the use of a new microorganism be supplemented by the deposit of the microorganism in a recognized culture collection. The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was introduced in 1980 in an effort to implement such recommendations. The Budapest Treaty recognizes 'international' depositary authorities for microorganisms, sets out the minimum standards for such collecting authorities, and also sets out the guidelines for the deposit of microorganisms. This treaty enables the deposit of the microorganism to help to satisfy the patentability requirements and also ensures that the microorganism is fully disclosed to the public.
The term "microorganism" is not defined in the Treaty. Whether a particular deposit is a microorganism or not matters less than whether the deposit is necessary for the purposes of disclosure. Tissue culture and nucleic acid molecules e.g. plasmids, can be deposited under the Treaty, even though they are not strictly microorganisms.
Under the Treaty, certain culture collections are recognized as "international depositary authorities" (IDA) and a deposit made in the IDA is recognized by all Contracting States to the Treaty. The microorganisms that are deposited with the IDA are kept for a period of at least thirty years or five years after the most recent request for a sample (whichever is longer). The Treaty does not specify at which point during the patenting process the sample must be deposited by the inventor; this is governed by national law. National laws also govern the conditions under which the samples can be accessed by other interested parties.
Currently, there are 58 Contracting States to the Budapest Treaty (as of 15th October 2003), including the United States and Australia. The European Patent Organization has also formally declared its acceptance of the Treaty.
The Food and Agriculture Organization (FAO) was set up in 1945 as a specialized agency of the UN. Its aims are to raise levels of nutrition, increase standards of living, improve agricultural productivity and to better the conditions of rural populations. The FAO recognizes the importance of biotechnology in achieving its aims, particularly in increasing productivity for food security. However, it also recognizes potential risks to humans, the environment and biodiversity from biotechnological applications.
The FAO administers many international treaties, of which the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) is just one.
The FAO has 188 member states (as of 29 November 2003) and the European Union is its only member organization..
The exchange of crops and their genetic resources is the backbone of the world's agricultural industry. In order to improve crop production and crop quality and produce enough food to sustain, and provide for the increase in, the world’s population, it is necessary for producers and farmers to be able to exchange plant genetic resources.
The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) is the result of seven long years of negotiations. The treaty aims at establishing an efficient and effective way of facilitating access to plant genetic resources while sharing the benefits from such a system in a fair and equitable way. While it is similar in principle to the CBD, the ITPGR specifically addresses the access and fair-sharing of the benefits of genetic resources in the food and agriculture industries.
Given that sustainable use of plant genetic resources is crucial to food security, the ITPGR aims to guarantee security through the conservation, exchange and sustainable use of the world's plant genetic resources. It also recognizes farmers' rights to freely access genetic resources, and to use and save seed under their national laws.
Through the treaty, the production of a commercial product which is developed using these resources results in the distribution of any monetary benefits to members of the treaty on the provision that the technology may be used without restriction.
While the ITPGR was adopted in November 2001, the treaty only entered into force on 29 June 2004 when 40 member countries ratified it. France was the latest party to approve the treaty, which brought the total number of parties to 73 as of 12 December 2005. Whilst the United States has signed the treaty, it has not ratified it. View current list of signatories on the FAO website.
The United Nation's Environment Program (UNEP) was established in 1972 to "act as a catalyst, advocate, educator and facilitator to promote the wise use and sustainable development of the global environment". UNEP aims to encourage caring for the environment, enabling people to improve their quality of life without compromising that of future generations.
UNEP oversees a number of international Agreements and Treaties, including the Convention on Biological Diversity (CBD).
The Convention on Biological Diversity (CBD) was established as a result of the United Nations Conference on Environment and Development (the "Earth Summit") in 1992. It was implemented under the United Nations Environment Program and currently has 168 signatories. Notably, the United States has not ratified the treaty, although the U.S. government has agreed to abide by it.
The CBD has three main objectives. They are:
1) to ensure conservation of biological diversity;
2) to ensure the sustainable use of biological diversity; and
3) to promote a fair and equitable sharing of the benefits arising from the utilization of genetic resources amongst member countries
Signatories to the CBD work towards obtaining a sustainable use of biodiversity through the establishment of a system of access that permits not only the control and preservation of each country's genetic resources, but also monitors the environmental impact resulting from this access.
A 'fair and equitable' sharing of the benefits includes granting appropriate access to genetic resources and allowing the facilitated transfer of relevant technologies.
The Convention states that each country has the sovereign authority to determine access to its own genetic resources and is entitled to benefit from the commercial use of such resources. Benefit is acquired through participation in research using the resources, by receiving technology which embodies the resources, and sharing the financial benefits from commercial exploitation of the genetic material or resource.
Given that the private ownership over genetic resources can now be granted (i.e. through patents or Plant Breeder's Rights) as a result of the TRIPS agreement and other international agreements, the CBD, by recognizing sovereign rights over private rights is perceived by some as a contradiction of some of these provisions.
The CBD and TRIPS approach the subject of intellectual property protection from the completely different perspectives of biodiversity and biotechnology, respectively. The implementation of the TRIPS agreement may affect the ability of WTO member countries to fulfill the CBD, and many countries are calling for amendments to be made to the TRIPS agreement in order to bring it into line with the CBD. (For further reading on this subject, see the IPR Commission website).
Adopted on 29 January 2000, the Cartagena Protocol on Biosafety functions as a supplementary agreement to the Convention on Biological Diversity. Utilizing a precautionary approach, the Protocol aims to maintain biological diversity in the face of potential risks posed by living modified organisms. Instruments of ratification or accession from 127 countries have been deposited with the UN Secretary-General (as of 6 November 2005). Notably absent among participating countries are Australia and the United States.
Why was the Protocol created?
During the negotiation of the Convention on Biological Diversity, it was recognized that when biotechnology is used in conjunction with adequate safety measures (having regard to both human and environmental health), it could contribute towards the achievement of Convention objectives. As a result, Article 1 of the Protocol (Objectives) reads:
In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.
The Precautionary Approach
The 'precautionary' approach utilized by the Protocol aims to avoid harm before it occurs. It is based on the premise that where threats of serious or irreversible damage exist, lack of scientific certainty should not provide the basis for delaying the implementation of measures designed to avert damage.
Article 3 of the Protocol defines Living Modified Organism (LMO) as meaning "any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology". It further defines Living Organism as meaning "any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids". Under these definitions, LMOs intended directly for 'food, feed or processing' (such as genetically modified soy, corn and canola) fall within the scope of the Protocol. The Protocol does not extend to processed foods derived from LMOs such as vegetable oils or peanut butter, nor does it extend to LMOs which are pharmaceuticals directed to humans and which are addressed by other relevant international agreements or organizations.
The AIA, which forms the core of the Protocol, deems that for certain LMOs in international trade, the exporting Party must provide written notification to the importing Party prior to trade in the LMOs, in order to allow the importing Party to conduct appropriate science-based risk assessment procedures, the outcome of which can result in approval of the intended import (with or without conditions), prohibition of the import, or a request for additional information. Exclusionary provisions extend coverage of the AIA to only certain traded LMOs - seeds and microorganisms that are destined for direct introduction to the environment.
Regulation of trade in other LMOs to be used in 'food, feed or processing' LMOs does not invoke the AIA Procedure. Under Article 11 of the Protocol, the requirement of prior written notification in the AIA is replaced with the requirement that importing Parties must proactively advertise applicable restrictions/regulations in the Protocol's Biosafety Clearing-House.
The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization which was established in 1961 by the UPOV Convention. The 1961 Convention was initially ratified in 1968 by the United Kingdom, Germany and the Netherlands. Since that time membership has grown to 53 countries, including the United States, Australia, China, 25 European countries and most recently, Tunisia. Notably, India is not a member. The Convention has been revised three times (in 1972, 1978 and 1991). Given that UPOV is a separate intergovernmental organization and not a 'treaty', the organization has its own standing and is only partially monitored by WIPO.
The aim of the Convention is to protect new plant varieties by an intellectual property right, while at the same time encouraging the development of new plant varieties.
The most recent UPOV Convention (1991) requires that member countries provide protection to new plant varieties by way of an exclusive property right, often called "Plant Breeder's Rights" (PBRs). The goal of PBRs is to provide an incentive to individuals or companies to invest in plant breeding and therefore add to the wealth of the community. Plant Breeder's Rights grant a legal monopoly over the commercialization of new plant varieties to the plant breeder, which allows them to try to recover the costs associated with breeding new plant varieties. The rights are granted for a limited period of time, at the end of which the protected variety passes into the public domain.
It is not necessary for all member countries to be bound by the 1991 Convention. Original UPOV members may elect to remain bound by a previous agreement, and as a result 26 countries are bound by the 1978 Convention. Spain and Belgium are the only countries that remain bound by the 1961 Convention.
The main differences between the 1978 and 1991 agreements are in the provisions defining the limits of the PBR protection and are presented in the table below:
|Protects||Commercial use of reproductive material of the variety||All plant varieties and products including those that are derived (Article 1)|
|Duration of protection||15 years from application date (18 yrs for trees and vines)||20 years from application date (25 yrs for trees and vines)|
|Breeder's Exemption||Yes||Optional to contracting states under Article 15(2)|
The 1991 Convention requires that the varieties are new - new in the sense that they have not been previously commercialized or sold prior to the UPOV application being submitted (subject to the grace period outlined in Article 6(1b)). The 1991 Convention also confers protection to 'essentially derived varieties,' i.e. plants which require the protected variety for their production (Article 14(5)). Unlike the previous UPOV agreement, there is no farmer's or breeder's exemption for protected species. It is now up to the national governments to implement separate legislation with respect to this practice.
Many UPOV members are also WTO members and are therefore obliged to allow claims to exclusive right of some duration over plant varieties (as a result of the TRIPS Agreement). The use of the UPOV plant protection system generally fulfills this requirement.